FDA 510(k)

PICO 7 Single Use Negative Pressure Wound Therapy System

N.º K: K172005 · 2018-02-02

SolicitanteSmith & Nephew Medical Limited

Fecha de decisión2018-02-02

Código de productoOMP

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

PICO 7 Single Use Negative Pressure Wound Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2018-02-02 under 510(k) number K172005. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PICO 7 Single Use Negative Pressure Wound Therapy System?

PICO 7 Single Use Negative Pressure Wound Therapy System is a medical device that received FDA 510(k) clearance on 2018-02-02. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K172005.

When did PICO 7 Single Use Negative Pressure Wound Therapy System receive FDA 510(k) clearance?

PICO 7 Single Use Negative Pressure Wound Therapy System received FDA 510(k) clearance on 2018-02-02, under 510(k) number K172005.

Who is the listed applicant for PICO 7 Single Use Negative Pressure Wound Therapy System?

The FDA 510(k) record lists Smith & Nephew Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PICO 7 Single Use Negative Pressure Wound Therapy System?

The FDA product code for PICO 7 Single Use Negative Pressure Wound Therapy System is OMP.

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Otros registros que enlistan a Smith & Nephew Medical Limited como solicitante

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Dispositivos relacionados (Código: OMP)

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.